Regulatory Affairs Specialist

3 weeks ago

Murrysville, Pennsylvania, United States Intellectt Inc Full time

Intellectt Inc is seeking a highly skilled Regulatory Affairs Specialist to support manufacturing line transfer activities.

Key Responsibilities:

  • Ensure regulatory compliance during manufacturing line transfers.
  • Support validation activities, including Installation Qualification, Operational Qualification, and Performance Qualification.
  • Assist in preparing and reviewing regulatory documentation.
  • Manage engineering change control processes.
  • Identify and address Non-Conformance Reports and Corrective and Preventive Actions.
  • Design and analyze trials using statistical methods.

Requirements:

  • Bachelor's degree in Engineering, Regulatory Affairs, or a related field.
  • 7+ years of experience in regulatory affairs, particularly in manufacturing line transfers.
  • Strong understanding of validation activities and engineering change management.

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